Avenga is a global IT and digital transformation champion. We deliver strategy, customer experience, solution engineering, managed services, software products and outsourcing services like: staff augmentation, team leasing and permanent employment.
Together, we are more than 2500 professionals with over 20 years of experience. We are present in Europe, Asia and the USA.
IT Compliance Lead
Miejsce pracy: Gdańsk
Nr ref.: ADR/ITCL/WAR/02/P
Nr ref.: ADR/ITCL/WAR/02/P
Job description:
- Support the information technology compliance program and provide operational leadership for IT compliance.
- Ensure that the company meets its IT compliance obligations, working in partnership with all departments within IT and other key stakeholders in the company that include Internal Audit, Legal, Quality and HR.
- Provide leadership to ensure adherence to the organization’s IT SOPs, IT Controls framework and System Development Life Cycle (SDLC), ensuring current projects meet business and regulatory requirements.
- Act as primary contact with responsibility for responding to all IT related audits and privacy related inspections, work in collaboration with Financial SOX, and GMP related systems.
- Responsible for IT privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements.
- Responsible for response and management of IT related audit activities.
- Provide leadership in developing responses to external and internal audit findings and managing execution of mitigation activities.
- Develop and implement processes to ensure that information systems are implemented and maintained according to corporate policies and regulatory requirements including data privacy.
- Provide guidance and oversight of computer systems quality and compliance activities, including the review and approval of compliance deliverables as appropriate.
- Support the organization's IT System Development Life Cycle (SDLC) ensuring that current business and regulatory requirements are satisfied. Establish a framework to monitor and audit adherence to SDLC via our stage gate process.
- Collect, evaluate and prioritize opportunities to improve compliance, privacy, and SDLC related policies and procedures. Report, analyze, audit and develop plans and programs to support continuous quality improvement.
- Manage the relationship between IT and other cross-functional groups and organizations that involve Audit, QA, compliance, privacy, and system validation practices. Leverage relationships to effectively enhance corporate and IT initiatives for these areas.
- Facilitate the firm-wide information security and internal audit program and help to ensure timely submission, tracking of issues, and facilitating remediation efforts
- Management of remediation tracking efforts for information system / security related assessments, escalating issues where appropriate, and validating that plans are implemented in a timely and effective manner
- Work with various members of the Information Protection Group to help ensure that the controls catalog is updated to reflect current risks
- Build, maintain and ensure adherence to the IT Governance Risk & Compliance framework.
- Act as the IT controls knowledge expert and point person by working and coordinating with management, audit and other areas of the organization.
- Assist management in monitoring IT audit remediation efforts.
- Coordinate and prepare reports for various technology management committees with a focus on accuracy, consistency and clarity.
Requirements:
- Bachelor's or master's degree in computer science, information systems, business administration or related field; or equivalent work experience.
- Solid grounding and practical experience in working in the pharmaceutical environment, with experience of Compliance, CSV, Quality, IT
- Experience of GAMP 5 and working within a GxP environment.
- Good background in auditing.
- Ability to write persuasive and effective reports and communications, which clearly define findings and their causes, and recommendations made.
- Must possess strong analytical skills. The ability to systematically gather information from a variety of sources, analyses information, identify implications of data, draw appropriate conclusions, generate viable alternative solutions to a question or problem and have the ability to apply
- Quality Risk Management processes to evaluate the consequences of choosing each alternative.
- The candidate must have an engaging style in order to successfully deliver
- Fluent English (spoken and spoken and written)
- Pracę zdalną lub w jednym z naszych biur- do wyboru
- Stały rozwój kwalifikacji zawodowych, wymiana doświadczeń
- Stabilną pracę wśród profesjonalistów
- Urozmaicony zakres prowadzonych projektów
- Dofinansowania do szkoleń i certyfikatów
- Prywatną opiekę medyczną
- Pakiet rekreacyjno- sportowy